Recall Z-0815-03 ยท ISY Joint, Knee, External Limb Component
Ossur North America Inc
Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
| Date | May 14, 2003 (initiated Mar 17, 2003) |
| Status | Terminated |
| Reason | Knee frame defect lead to breakage and injury. Knee bolt end came loose. |
| Root cause | Other |
| Action | Firm called customers by phone and sent recall letters 3/17/2003. |
| Quantity | 261 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.